Events

Recall of Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LMA North America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62337
  • Event Risk Class
    Class 2
  • Event Number
    Z-2022-2012
  • Event Initiated Date
    2012-05-23
  • Event Date Posted
    2012-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110279
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Reason
    The recall was initiated because lmana has received a complaint that the esophageal intubation detector (eid100) has a potential to create a false positive if used on a patient during confirmation of intubation.
  • Action
    LMA North America Inc. sent a recall letter dated May 23, 2012, for US customers, and May 24, 2012, for International customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to fill out the bottom portion of the recall letter and promptly fax it back to LMA North America at (858) 622-4130. If customers have units of EID100 from the affected lots remaining in stock, customers were instructed to arrange for immediate return by contacting LMANA's customer service department at (800) 788-7999, menu selection #2. For further questions please contact Customer Service Representative at (800) 788-7999.

Device

Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100
  • Model / Serial
    2009 Lot # 90923A, 91222A. 2010 Lot# 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A.  2011 Lot# 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A. 2012 Lot# 120104, 120414.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
  • Product Description
    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 || The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
  • Manufacturer
    LMA North America Inc

Manufacturer

LMA North America Inc
  • Manufacturer Address
    LMA North America Inc, 4660 La Jolla Village Dr Ste 900, San Diego CA 92122-4608
  • Manufacturer Parent Company (2017)
    Lma North America, Incorporated
  • Source
    USFDA